POSLUMA® PET-CT for Uncertain Prostate MRI Results
This study is testing if a special scan, called POSLUMA® (18F-rhPSMA-7.3) PET-CT, can better find serious prostate cancer in men who have unclear results from a regular MRI. These unclear MRI results are called PIRADS 2 or PIRADS 3. The researchers want to see if using this new scan is more accurate than just doing a biopsy based on the MRI alone. You might be able to join if you are a man at least 18 years old and have not had a prostate biopsy before. The study will look at how well the scan predicts if cancer is present or not, and its overall accuracy, over about 12 weeks. The study plans to enroll 30 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 30 men to test the effectiveness of a new imaging agent. The phase of the study is not specified.
- What's involved
- You would receive a single dose of Flotufolastat F 18 for a PET scan. The study will track your progress from enrollment to about 12 weeks after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment to the end of treatment visit, which is roughly 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Change in positive predictive value (PPV)From enrollment to the end of treatment visit at roughly 12 weeks.
Evaluate the change in PPV for detecting clinically significant prostate cancer (csPCa) cores by comparing results from mpMRI alone (PIRADS 2 and 3 lesions) to the combination of mpMRI with flotufolastat F 18 PET-CT.
- Change in negative predictive value (NPV)From enrollment to the end of treatment visit at roughly 12 weeks.
Measure the change in NPV for detecting csPCa cores by comparing mpMRI findings alone (PIRADS 2 and 3 lesions) with the combined approach of mpMRI and flotufolastat F 18 PET-CT.
- Improvement in AccuracyFrom enrollment to the end of treatment visit at roughly 12 weeks
Assess the improvement in accuracy (accuracy defined as \[(true positive + true negative) / total number of subjects\] when using the combined imaging approach of flotufolastat F 18 PET-CT with mpMRI versus mpMRI alone in patients with PIRADS 2 and 3 lesions.